Novaestiq’s Partner Croma-Pharma Announces Submission to the U.S. Food and Drug Administration for saypha® MagIQ

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1st submission in the United States for saypha® line of dermal fillers represents a key Novaestiq milestone

SOUTHLAKE, TX, UNITED STATES, August 21, 2024 /EINPresswire.com/ — Novaestiq Corp., a growth-oriented aesthetic company that focuses on delivering intelligent and innovative skin solutions to practices and patients announced today that earlier this year its partner Croma-Pharma GmbH finalized submission of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the saypha^® MagIQ hyaluronic acid dermal filler. Novaestiq plans to commercialize saypha^® MagIQ beginning in early 2025.

“We are delighted that our partner Croma has submitted this first filler product to the FDA,” said Miles Harrison, Chief Executive Officer, Novaestiq. “The submission is a foundational milestone for Novaestiq and supports our effort to create the next great aesthetic company. We look forward to continued collaboration with our partners at Croma as we drive our “Aesthetics for All” ethos.”

The PMA application includes results from the U.S. pivotal study, which evaluated the safety and effectiveness of the products in a multicenter, blinded, split face, controlled, non-inferiority designed trial. Patients were followed for 12 months from initial treatment. A total of 270 patients were enrolled and received saypha^® MagIQ in one NLF and Juvederm^® Ultra XC in the contralateral NLF. saypha^® MagIQ met the primary endpoint at 24 weeks. Additional information will be shared at upcoming medical conferences.

saypha^® MagIQ has 8+ years of global experience and is manufactured by Croma in Leobendorf, Austria. More than 22 million syringes have been manufactured from the saypha^® product line demonstrating high quality, a proven safety profile, and consistent performance in over 80 markets around the world. Novaestiq anticipates that their partner Croma will be submitting a second filler product for approval early in 2025.

About Novaestiq

Novaestiq is a private, growth-oriented company that boasts a broad range of aesthetic and dermatology products that are both practice and patient/consumer focused. Novaestiq is poised to bring a variety of intelligent and innovative skin solutions to the market in the coming months and years. With a strong emphasis on driving practice success, Novaestiq is set to redefine industry standards. www.novaestiq.com

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Drew Fine, Chief Commercial Officer. Email: [email protected]

Media Relations Novaestiq Corp. Email: [email protected]

Drew Fine
Novaestiq
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